Description
In this exciting new challenge, you will embark on a strategic role with added operational responsibilities thrown into the mix, supporting my client, a global Pharmaceutical company, who have a great range of both small molecules and biologics candidates.You will primarily be designing and conducting toxicology studies to ensure compliance with regulatory requirements and company policies to enable projects to advance. You will develop strategies to better understand target and asset-specific toxicology of innovative new candidates,
Responsibilities:
- Define toxicology-related stage-gating criteria and preclinical milestones to inform decision making across research.
- Develop in-depth understanding and strategy for management of target and asset-specific liabilities.
- Develop and implement toxicology strategy for lead optimization and candidate selection.
- Identify collaborative opportunities in toxicology science consistent with the strategic focus of internal discovery therapeutics.
- Design and implement nonclinical investigative toxicology studies.
- Conduct studies and participate in activities related to the Investigational New Drug (IND) application and other regulatory approvals.
- Work closely with clinical sciences to support planned or ongoing clinical trials in terms of safety assessment and better understanding liabilities related to target and asset specific mechanisms.
- Advise discovery teams with toxicology input and to establish and maintain highly functional interfaces with clinical sciences and other development teams.
- Establish external collaborative partnerships and for negotiating and closing collaborative deals related to investigate or regulatory toxicology studies.
Requirements
- PhD with Post-doc in toxicology disciplines
- Experience in immune-oncology or molecular Toxicity
- Experience demonstrating sustained record of achievement and ability to understand translational pathobiology
- Preferably Board certification in toxicology
- Broad technical expertise and experience in vitro and in vivo models to address safety issues
- Understand cutting-edge sciences and technology applied to enhance investigations of drug candidate safety liabilities.
- Experience interacting with regulatory bodies
- You will travel up to 10% of the time at international levels
Please send CVs or call
Michael Bailey International is acting as an Employment Agency in relation to this vacancy.